News | March 9, 2001

Synagis humanized monoclonal antibody protects premature babies from respiratory virus

What are the ingredients of a successful business partnership?

For Abbott and MedImmune, Inc., it is the combination of an innovative pediatric product and the industry's leading pediatric sales force.

The two companies have worked together to bring to market Synagis (palivizumab), the world's first genetically engineered treatment for preventing respiratory syncytial virus (RSV), a serious and sometimes fatal respiratory infection in infants. RSV is a leading cause of bronchiolitis (inflammation of the smaller airways of the lungs) and pneumonia in infants and children.

In the pivotal clinical trial of Synagis, the incidence of hospitalization of premature infants and infants with lung disease treated for RSV was reduced by 55 percent. With these compelling results, the product received rapid approval by the U.S. Food and Drug Administration in June 1998.

"Now we have a drug that can protect at-risk babies from a disease that, in some cases, has meant certain death," says Jessie Groothuis, M.D., medical director of immunology, Scientific Affairs, Abbott International. "That's a very comforting feeling."

How Does Synagis Work?
First of all, because Synagis is a preventive agent, it may seem like a vaccine—but it isn't. In fact, it is a humanized monoclonal antibody—in other words, a genetically engineered antibody that mimics those produced naturally in humans

Unlike a vaccine, which uses dead or weakened viruses to induce an antibody response in the body, Synagis provides its own antibodies to fight the virus, giving a patient "passive immunity."" It's similar to the type of immunity a mother naturally passes on to her baby during the last three months of pregnancy," Groothuis says.

However, many premature infants are born before the mother's antibodies can be passed along, she explains. Their lungs and immature immune systems often aren't strong enough to ward off the RSV infection.

The virus usually causes little more than a cold in most children, but for at-risk babies, RSV can be deadly. The thick secretions can choke off a baby's air supply.

The course of treatment with Synagis consists of a series of shots given a month apart in the doctor's office during the RSV season. The shots are delivered through an intramuscular injection. Once the antibodies are inside the body, they bind with a protein, located on the surface of RSV, that allows the virus to fuse with the cells lining the respiratory tract. This binding process disables the RSV "F" (for fusion) protein and prevents the virus from invading and infecting healthy respiratory cells.

The Benefits
In addition to the therapeutic benefits of Synagis, there now is evidence to demonstrate its cost-effectiveness, as well. The findings of one economic study, presented at the 1999 Pediatric Academic Societies' annual meeting in San Francisco, show that the use of Synagis reduced RSV-related hospitalization and costs associated with treating the disease. According to the study, average per-patient savings were $39,107.

Another benefit of Synagis: It's produced by recombinant biotechnology and synthesized from an endless supply of cultured antibodies, which means there are virtually no limitations on supply. And, because the product isn't derived from human blood, it is extremely safe.

Groothuis says. "The positive impact that Synagis will have on the lives of many high-risk infants and children should be extremely rewarding for all of us."